This invention relates to immunoassay procedures and, in particular, to an assay for the detection of interferon epsilon, an antiviral agent produced by human epithelial cells.
Interferons are materials which have antiviral properties. They are produced by certain types of cells which have been stimulated by exposure to a virus, certain nucleic acids, or antigen/mitogen complexes. Interferons are extremely potent drugs which show great promise as clinical antiviral agents.
Human interferons typically are divided into three types: interferon alpha, produced from human leukocytes or lymphoblastoid cells; interferon beta, produced from fibroblasts; and interferon gamma, produced from human T-lymphocytes. All three are secreted by the respective cells after the cells are stimulated by a virus or an analogous challenge.
U.S. patent application Ser. No. 397,610 now abandoned entitled "Interferon-E" filed July 12, 1981, and a continuation-in-part thereof, Ser. No. 628,327 now U.S. Pat. No. 4,614,651 filed herewith and having the same title, disclose the existence of a fourth type of interferon, called interferon epsilon or interferon E, derived from human epithelial cells. The disclosures of both of these commonly assigned patent applications are hereby incorporated by reference.
Interferon epsilon is active on human epithelial cells and therefore holds promise in augmenting the body's first line of defense, e.g., the skin and other epithelial surfaces, against viral attack. However, because interferon epsilon is active only in the epithelium, conventional tests for interferons are inadequate to detect and quantify its presence. Thus, there exists a need for a simple, effective assay to detect the presence of interferon epsilon and quantify its titer. Such an assay would be useful in laboratory settings as well as in quality control procedures in the manufacture of interferon epsilon for therapeutic use.